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Humira Level

my little penguin

Moderator
Staff member
Adalimumab Level for IBD - The American Gastroenterological Association recommends optimal adalimumab trough concentration of 7.5 mcg/mL or greater in patients with active IBD. Data from separate clinical studies suggest an optimal adalimumab trough concentration greater than 4.5 mcg/mL or 8-12 mcg/mL. Sub-therapeutic adalimumab levels may be due to a patient not yet achieving a steady state trough level early in therapy, inadequate dosing, a dosing interval that is too long or accelerated adalimumab clearance. Accelerated adalimumab clearance may be explained by the presence of adalimumab anti-drug antibody or rheumatoid factor in the patient's serum, or may be caused by other diseases that indirectly lead to immunoglobulin loss (i.e. kidney disease, protein-losing gastroenteropathy). If the steady state trough adalimumab level is low despite adequate dosing, adalimumab anti-drug antibody testing should be considered.
from

 

my little penguin

Moderator
Staff member
Abstract
Background: Adalimumab is an established treatment for Crohn's disease. Limited data are available regarding the relationship between adalimumab drug levels and serum/fecal markers of gut inflammation. We therefore aimed to characterize the relationship between adalimumab levels and biologic remission during maintenance therapy.
Methods: A single-center prospective cross-sectional study was undertaken on Crohn's disease patients who had received adalimumab therapy for a minimum of 12 weeks after induction. Data on clinical activity (Harvey-Bradshaw Index), C-reactive protein (CRP), adalimumab drug and antibody levels, and fecal calprotectin were collected. Biologic remission was defined as a CRP <5 mg/L and fecal calprotectin <250 µg/g. Adalimumab drug and antibody levels were processed using the Immundiagnostik monitor enzyme-linked immunosorbent assay.
Results: One hundred fifty-two patients had drug and antibody samples matched with CRP and fecal calprotectin. Patients in biologic remission had significantly higher adalimumab levels compared with others (12.0 µg/mL vs 8.0 µg/mL, P < 0.0001). Receiver operating characteristic curve analysis demonstrated an optimal adalimumab level of >8.5 µg/mL (sensitivity, 82.2%; specificity, 55.7%; likelihood ratio, 1.9) for predicting biologic remission. Multivariable logistic regression revealed that adalimumab levels >8.5 µg/mL were independently associated with biologic remission (odds ratio, 5.27; 95% confidence interval, 2.43-11.44; P < 0.0001).
Conclusions: Higher adalimumab levels are associated with biologic remission. An optimal level of >8.5 µg/mL was identified.

From
 
We haven’t talked to the GI yet since it’s late in the evening, but it seems that 5.13 is a little low. He gets Humira every 2 weeks, so I wonder if he would benefit from more frequent injections…? Thoughts on a level of 5.13??
 

my little penguin

Moderator
Staff member
The two reports I posted stated 7.5 or 8.5 is needed .
Depends on antibodies as well
Did it show antibodies to humira ???
Adding mtx boosts humira , as does weekly doses
Sometimes they add all three things at once (mtx, higher humira at weekly doses and een )
Then hope for the best
Later once in remission dropping things off
 
Last time we talked to the GI, she mentioned if levels are low ,maybe trying Humira every 10 days vs 14. But, would 4 days really make a difference? She didn’t mention weekly…
Also, as bridge therapy while waiting for Humira to work better, is it more common to throw in an oral steroid or try something like Methotrexate?
 

my little penguin

Moderator
Staff member
So when my kiddo was on humira (over 5 years)
First year or so was every 2 weeks
Then he developed juvenile arthritis so
Moved humira to every 10 days
Waited added methotrexate for peripheral joints inflamed
Then added Celebrex as well
After a year or so
Moved humira to every 7 days
Then another year or moved to every 5 days
We squeaked another year out of that so ….
5 plus years on humira

so most don’t jump to every 2 weeks to every 7 days is my point

mtx takes 12 weeks to be effective so not a true bridge
It just boost humira by lower the inflammation humira has to fight
Immediate relief is from formula only and/or oral steroids
While weaning off steriods the mtx is started with the higher frequency of humira typically …
Or just humira
Depends on how aggressive the docs treatment plans
 

Maya142

Moderator
Staff member
My older daughter went from Humira every 14 days (which helped some, but not enough) to every 7 days and that really helped her. She was already on MTX though. She was put on a low dose of oral steroids while we waited for Humira to kick in.

My younger one went from Humira every 14 days (which didn't help enough, if at all) to every 10 days (helped a little) to every 7 days (helped more), then added MTX. Humira + MTX worked like magic for her, though it did take 6 months to work. In hindsight, I'm not sure why we stuck to it so long, perhaps because there were fewer biologics around back then, but I'm so glad we did because at every 7 days, with MTX, it made a huge difference for her - it was really incredible. Later, she moved to every 6 days.

At the time (this was more than 10 years ago), the Humira levels test was not available, so we just went by symptoms.

MTX could definitely help but as said above, it's not really a bridge - more of an add-on therapy. For a bridge, GIs usually use steroids or EEN. There are pros and cons to both. EEN is tougher for kids to do but it actually heals the bowel better. Steroids are easier to take, but come with all sorts of side effects.

Now many GIs will allow a small amount of food with formula - so like 90% formula and 10% food or 85%/15% formula/food - to make it easier for the kiddo. Other docs are stricter and insist on 100% formula, usually for 6-8weeks, though it can be used for longer. Some kids prefer drinking the formula and others require NG tube feeds.
Good luck!
 
Thank you so much for your response!

For oral steroids, did your GI ever use Uceris (Budesonide), or was it always Prednisone?
My son has been on Prednisone once at the very beginning, but it’s the only steroid his GI has mentioned. As I’ve been reading throughout the forum, some have said Budesonide has helped and it’s a bit milder on the side effects vs Prednisone. I wonder if it’s worth pushing Budesonide, or is there a reason Prednisone seems to be the go to?
 

crohnsinct

Well-known member
Generally to induce a remission the pediatric GI’s will go with prednisone over budesonide because it has a higher success rate.
As I mentioned in one of your other threads my older daughter had trouble getting Remicade to get hold of the disease even though she was at max dose and every 4 weeks. She did 6 weeks of EEN and since EEN brings down inflammation but also heals the mucosa, she got to a real good remission and the Remicade was able to hold it.

That level is low for Humira so moving to every week or even every 10 days might help. The addition of mtx could also help. But it also depends on what the antibodies are.

One other thing pediatric docs have found is that kids with active inflammation and their high metabolisms need a much higher trough level than adults. Inflammation alone sops up the drug and you actually end up pooping a lot of it out. So while a level of 5 is the published level for Remicade my daughters’ Docs shoot for a level greater than 10 when inflammation is present. Then when in remission you could start to cut back a little.

Good luck and Keep us posted
 
Generally to induce a remission the pediatric GI’s will go with prednisone over budesonide because it has a higher success rate.
As I mentioned in one of your other threads my older daughter had trouble getting Remicade to get hold of the disease even though she was at max dose and every 4 weeks. She did 6 weeks of EEN and since EEN brings down inflammation but also heals the mucosa, she got to a real good remission and the Remicade was able to hold it.

That level is low for Humira so moving to every week or even every 10 days might help. The addition of mtx could also help. But it also depends on what the antibodies are.

One other thing pediatric docs have found is that kids with active inflammation and their high metabolisms need a much higher trough level than adults. Inflammation alone sops up the drug and you actually end up pooping a lot of it out. So while a level of 5 is the published level for Remicade my daughters’ Docs shoot for a level greater than 10 when inflammation is present. Then when in remission you could start to cut back a little.

Good luck and Keep us posted
Thank you again for your response! This really makes a lot of sense.
My son recently started Uceris foam. Would that be considered a “bridge therapy” to induce remission and help the Humira? Or maybe it wouldn’t be considered bridge therapy since it only reaches up to the Sigmoid colon. I assume only the oral steroid would be able considered bridge therapy to induce remission, rather than topical (rectal) steroids, correct?
 
@my little penguin @Maya142 @crohnsinct
The nurse from the GIs office called to let me know the GI reviewed my son’s Humira level, and because it’s higher than 4.9 (his is 5.13) she does not want to increase the frequency at this time. Right now, he does Humira every 2 weeks and is doing a 6 week course of Uceris foam. Since starting Uceris, the urgency and frequency have gotten a little better, but he still has blood in most of his BM’s. The GI said she wants him to stay the course and update her a week before the last week of the 6 week Uceris course.
Is it at all possible the Uceris foam could help enough to get the Humira to work better? If the bleeding, urgency, frequency don’t resolve by the time the 6 week course of Uceris Foam treatment is up, I wonder if she’ll add in an oral steroid…I may ask about Uceris oral. The waiting game is the worst.
 

crohnsinct

Well-known member
In our experience and keep in mind O is at the most extreme end of the spectrum, the foal is not enough to get a kid to remission or help the drugs work better. It was a game changer in that it reduced frequency, urgency and bleeding but it did not change the disease course.

Honestly, I am surprised she is not moving to weekly injections, at least to get him to remission. Once in a solid remission, you could always move back out to every two weeks.

Oral Uceris also was not strong enough for O. She needs prednisone to knock her inflammation down but again she is at the extreme side of severe disease so it might be worth a shot.

I would consider a course of EEN. It is difficult for the kids but it is very effective at knocking back inflammation, inducing remission and healing the mucosa (which prednisone does not do). However, given your GI's position on all the other issues it might be hard to get her to agree to a course of EEN.

I would go ahead and pursue that second opinion.
 

crohnsinct

Well-known member
^ That! When O was meeting with the interventional radiologist he said pretty much the same. The suppository just reached rectum and the foam just the rectum and some of the sigmoid at best. However, given that is generally where the bleeding comes from, it is a good thing to keep up but I really don't think it is going to help the Humira work better.
 
At some point I may seek a 2nd opinion. But, he’s only 4 months in. Was diagnosed end of July. I’m trying to be patient and I do believe our GI is great, so I hate to rush into a 2nd opinion. Although, I realize it’s no biggie to get a 2nd opinion, so we’ll see how things go. I will keep that option in my back pocket. It seems that she wants to see how he does with the Uceris foam and if he starts improving. We’re supposed to provide an update in a few weeks so I’ll know more then.
Thank you again for your responses!!
 

Maya142

Moderator
Staff member
A second opinion appointment often takes months to get. So if you make the appt. now, then you'll likely see the doctor in a couple months (or longer). It's definitely not a big deal to get a second opinion - most GIs welcome it and if they don't, then there is a problem with the doc. Our GI suggested it more than once.

Is it at all possible the Uceris foam could help enough to get the Humira to work better? If the bleeding, urgency, frequency don’t resolve by the time the 6 week course of Uceris Foam treatment is up, I wonder if she’ll add in an oral steroid…I may ask about Uceris oral. The waiting game is the worst.
Uceris foam is not going to target the inflammation elsewhere - not in his small bowel or even higher up in his colon. It might help with the bleeding but only if the blood is coming from his rectum/sigmoid colon and it's topical, so it's not going to target inflammation in the deeper layers of his rectum. To be honest, I doubt it will help the Humira work better.

At 6 weeks, if your GI did add an oral steroid and didn't increase his Humira, I'd find that concerning too. Steroids are a short-term measure - you need the Humira to work, so the next step is upping the frequency of Humira. His Humira level is really on the lower end and quite often kids need higher trough levels than stated in the literature to induce remission and stay there.

Your son has been on Humira every 2 weeks for 4 months, right? Usually Humira takes 3 months to kick in, though it can take longer, up to 5-6 months in some cases. To me, it is also kind of surprising that she is not going to weekly shots since he's having clear IBD symptoms.

If it were my child, I would start the second opinion process now, since your appt. might be 3 months down the road. If he's doing great by then, you can always cancel it. But if you wait 6-8 weeks and only then start the process, your appt. may be 5 months away, which is a long time to wait when your kiddo is still having clear IBD symptoms.
 
Another question. The lab work that just came back showed my son’s vitamin D level at 23. I believe normal range begins at 30, so he’s just a little low. He’s been taking vit d3 2000 and the GI said to go ahead and double or triple it. Would it be safe to just give him 10,000 for a month or so just to bring up the level faster? I will ask her too, but wondering your thoughts and if anyone has had experience with vit D dosages.
 

my little penguin

Moderator
Staff member
Vitamin d is used by the body more when there is inflammation
So getting the inflammation down makes the 2000 iu better absorbed
If his inflammation is still high taking more vitamin D ….
 
I talked to our GI again about increasing Humira. She said although the higher goal Humira level has been reported . . . it does not follow FDA approved dosing standards (which is what insurance uses).
She’s going to submit a new rx for every 10 day dosing and await insurance response. I feel this is a step in the right direction. She still wants me to report any symptoms when we have about a week left of the Uceris Foam.
 

my little penguin

Moderator
Staff member
Get a second opinion
None of the kiddie ibd drugs used ever follow fda dosing standards
Those fda standards are a better fit for adults
And kids never get the memo
You need a doc who is willing to fight to get your child into solid remission not state (“I don’t want to fight insurance imo

my kiddo was on humira before it was fda approved at all for pediatric crohns
Stelara is still not approved for pediatric crohns
And the dose he needs (as does most pediatric crohns patient per old Gi ) is much higher than fda approved adult dose of 90 mg every 8 weeks .

you need to find a second opinion quickly
Not sure how else to word it


Our current Gi went to battle with insurance for 8 months to get Stelara REAPPROVED - at every 4 weeks since Ds was doing so well on that dose

You need a doc who is willing to battle to get the meds needed
 
We live in Nebraska. Not that we want to travel, but where/what GI does your kiddo see? What hospital/clinic?
I wonder if it makes sense to get a 2nd opinion from a place not in Nebraska since I don’t know if a good one here. Do places ever give 2nd opinions without having to travel a bunch?
 
Get a second opinion
None of the kiddie ibd drugs used ever follow fda dosing standards
Those fda standards are a better fit for adults
And kids never get the memo
You need a doc who is willing to fight to get your child into solid remission not state (“I don’t want to fight insurance imo

my kiddo was on humira before it was fda approved at all for pediatric crohns
Stelara is still not approved for pediatric crohns
And the dose he needs (as does most pediatric crohns patient per old Gi ) is much higher than fda approved adult dose of 90 mg every 8 weeks .

you need to find a second opinion quickly
Not sure how else to word it


Our current Gi went to battle with insurance for 8 months to get Stelara REAPPROVED - at every 4 weeks since Ds was doing so well on that dose

You need a doc who is willing to battle to get the meds needed
Update/Question:
So our GI is having him go ahead to Humira every 10 days vs every 2 weeks. He also has 4 weeks left of the Uceris foam treatment. What’s interesting is that some days the frequency and urgency are better, but then some days it’s not. For example, last week his frequency went from about 5 BMs to 3. But now he’s back at 5 BMs. Some days are better than others so there’s a lot of back and forth. We’ve always thought he had a little IBS and he’s been on medication for anxiety. Could it be a little IBS/anxiety that is causing some of the frequency/urgency?
 

crohnsinct

Well-known member
I think I responded on another thread re:IBS vs IBD. But in short the answer is yes. If he has anxiety some of the back and forth could be IBS related. Labs are helpful here. If fecal calprotectin is elevated then it is IBD related. If all labs are perfectly normal then there is a chance that it could be IBS related. All the things you would do for IBS (stress management, exercise etc) are also good for IBD so it is a win, win but I would be wanting some lab results before assuming it is IBS but it sounds like you doc is making a move with the Humira so that is good.
 
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